Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
FDA premarket approval P210037 · decided 2023-03-31
Approval details
- PMA number
- P210037
- Trade name
- Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Applicant
- Biotronik Nro, Inc.
- Date received
- 2021-12-02
- Decision date
- 2023-03-31
- Days to decision
- 484 days
- Decision code
- APPR
- Product code
- LGW
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- Approval for the Prospera Spinal Cord Stimulation (SCS) System, Resilience Percutaneous Lead, HomeStream Remote Management. The Indications for Use (IFU) of the device is as follows:The Prospera spinal cord stimulation (SCS) system is indicated as an aid in the management of chronic, intractable pain in the trunk and/or limbs, which may include unilateral or bilateral pain, resulting from any of the following: 1) Failed Back Syndrome (FBS) or low back syndrome or failed back; 2) Radicular pain s
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